MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 APP; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	PT-001788
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Urinary Frequency / Polyuria (2275); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	06/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that they sought medical attention at the hospital on (b)(6) 2025, due to an issue with the omnipod app being incompatible with their samsung device.This incompatibility led to symptoms such as vomiting, sweating, constant urination, and sleepiness, which resulted in a diagnosis of diabetic ketoacidosis (dka).The patient was hospitalized for three days, during which they received fluids, had their pod removed, were placed on an insulin drip, and had their blood glucose (bg) levels (over 250 mg/dl) monitored hourly.They were also put on a diabetic diet.After the medical event was documented, it was confirmed that the patient did not have access to any previously registered omnipod 5 controllers and had lost access to the omnipod 5 app due to the incompatibility.
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.No lot release records were reviewed, as the product lot number was not provided.High blood glucose is a common symptom for people with diabetes (glucose monitoring data from people with diabetes indicate that on average, they can experience blood glucose levels above 250 mg/dl for 14-25% of the time[1][2][3].), and it would be challenging to speculate on a cause for the complaints without receiving the devices back for an engineering investigation.[1] beck rw, bergenstal rm, cheng p, kollman c, carlson al, johnson ml, rodbard d.The relationships between time in range, hyperglycemia metrics, and hba1c.J diabetes sci technol 2019;13:614-626.[1] welsh jb, derdzinski m, parker as, puhr s, jimenez a, walker t.Real-time sharing and following of continuous glucose monitoring data in youth.Diabetes ther 2019;10:751-755 [1] puhr s, derdzinski m, welsh jb, parker as, walker t, price da.Real-world hypoglycemia avoidance with a continuous glucose monitoring system's predictive low glucose alert.Diabetes technol ther 2019;21:155-158.Locked down smartphone: phone_control_android omnipod software app version: 3.1.1 smartphone operating system: ap3a.240905.015.A2.S918usqs6dyf3 smartphone hardware: sm-s918u cgm sensor type: g7.Please note, that section d is capturing the device identifiers as reported by the complainant.This may not align to the device configuration reported in h11, as this data is pulled from our cloud based on the reported date of event.

• Brand Name: OMNIPOD 5 APP
• Common Device Name: ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 22535201
• Report Number: 3004464228-2025-31921
• Device Sequence Number: 7488081
• Product Code: QFG
• UDI-Device Identifier: 10385083000565
• UDI-Public: 10385083000565
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K203768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PT-001788
• Device Catalogue Number: M009-3P-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/17/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male